Device typeSilicone-block tissue reconstructive material: A non-sterile, solid chunk of silicone elastomer typically modified to suit the patient anatomy and implanted, after sterilization, for tissue reconstruction during a surgical procedure. The device is typically available as a cube with a rectangular cross-section or with curved surfaces. It may be carved or trimmed into different sizes and shapes for various reconstructive or cosmetic plastic surgery procedures that involve soft-tissue or bone augmentation, or the formation of prosthetic implants (e.g., chin or malar). This is a single-use device.
FDA categoryImplant, Muscle, Pectoralis
Device IDM724HTPI2LNS1
Catalog numberHTPI-2L-NS
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information